A Study of MK-8527 in Healthy Adult Participants (MK-8527-013)
June 10, 2025 updated by: Merck Sharp & Dohme LLC
A Phase 1 Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]MK-8527 in Healthy Adult Participants
The goal of this study is to learn how [14C]MK-8527 moves through a healthy person's body over time.
Researchers will study how [14C]MK-8527 is absorbed by the body, broken down by the body, and how it leaves the body.
Study Overview
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53704
- Fortea CRU Madison ( 0001)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Is in good health
- Has a body mass index (BMI) of 18 to 32 kg/m^2
Exclusion Criteria:
- Has a history of cancer
- Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: [14C]MK-8527
Participants will receive a single oral dose of [14C]MK-8527 on Day 1
|
Oral Dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative Percentage of Total Radioactivity Recovered (fe) from Urine and Feces
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Urine and fecal samples will be collected to determine the cumulative percentage of radioactivity recovered from both urine and feces.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Fe from Urine
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Urine samples will be collected to determine the percent of total radioactivity recovered from urine.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Fe from Feces
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Fecal samples will be collected to determine the percent of total radioactivity recovered from feces.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Plasma MK-8527: Area Under the Concentration-Time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)
Time Frame: At designated timepoints (up to 24 hours post-dose)
|
Plasma samples will be collected to determine the AUC0-24 of MK-8527.
|
At designated timepoints (up to 24 hours post-dose)
|
|
Plasma MK-8527: Maximum Observed Concentration (Cmax)
Time Frame: At designated timepoints (up to approximately 14 days post-dose)
|
Plasma samples will be collected to determine the Cmax of MK-8527.
|
At designated timepoints (up to approximately 14 days post-dose)
|
|
Plasma MK-8527: Concentration at 24 Hours Post-dose (C24)
Time Frame: At designated timepoints (up to 24 hours post-dose)
|
Plasma samples will be collected to determine the C24 of MK-8527.
|
At designated timepoints (up to 24 hours post-dose)
|
|
Plasma MK-8527: Time of the Maximum Observed Concentration (Tmax)
Time Frame: At designated timepoints (up to approximately 14 days post-dose)
|
Plasma samples will be collected to determine the Tmax of MK-8527.
|
At designated timepoints (up to approximately 14 days post-dose)
|
|
Plasma Total Radioactivity: AUC0-24
Time Frame: At designated timepoints (up to 24 hours post-dose)
|
Plasma samples will be collected to determine the AUC0-24 of total radioactivity.
|
At designated timepoints (up to 24 hours post-dose)
|
|
Plasma Total Radioactivity: Cmax
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Plasma samples will be collected to determine the Cmax of total radioactivity.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Plasma Total Radioactivity: C24
Time Frame: At designated timepoints (up to 24 hours post-dose)
|
Plasma samples will be collected to determine the C24 of total radioactivity.
|
At designated timepoints (up to 24 hours post-dose)
|
|
Plasma Total Radioactivity: Tmax
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Plasma samples will be collected to determine the Tmax of total radioactivity.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Whole Blood Total Radioactivity: AUC0-24
Time Frame: At designated timepoints (up to 24 hours post-dose)
|
Whole blood samples will be collected to determine the AUC0-24 of total radioactivity.
|
At designated timepoints (up to 24 hours post-dose)
|
|
Whole Blood Total Radioactivity: Cmax
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Whole blood samples will be collected to determine the Cmax of total radioactivity.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Whole Blood Total Radioactivity: C24
Time Frame: At designated timepoints (up to 24 hours post-dose)
|
Whole blood samples will be collected to determine the C24 of total radioactivity.
|
At designated timepoints (up to 24 hours post-dose)
|
|
Whole blood Total Radioactivity: Tmax
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Whole blood samples will be collected to determine the Tmax of total radioactivity.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Cumulative Amount of Radioactivity Recovered from Urine
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Urine samples will be collected to determine the cumulative amount of radioactivity recovered from urine.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Percent of Total Radioactive Dose Recovered from Urine
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Urine samples will be collected to determine the percent of the total radioactive dose recovered from urine.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Cumulative Amount of Radioactivity Recovered from Feces
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Fecal samples will be collected to determine the cumulative amount of radioactivity recovered from feces.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Percent of Total Radioactive Dose Recovered from Feces
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Fecal samples will be collected to determine the percent of the total radioactive dose recovered from feces.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Plasma samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity.
Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Urine samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity.
Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
|
Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity
Time Frame: At designated timepoints (up to approximately 5 weeks post-dose)
|
Fecal samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity.
Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
|
At designated timepoints (up to approximately 5 weeks post-dose)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 7 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
|
Up to approximately 7 weeks
|
|
Number of Participants Who Discontinue the Study Due to an AE
Time Frame: Up to approximately 7 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
|
Up to approximately 7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 19, 2025
Primary Completion (Actual)
June 4, 2025
Study Completion (Actual)
June 4, 2025
Study Registration Dates
First Submitted
February 10, 2025
First Submitted That Met QC Criteria
February 10, 2025
First Posted (Actual)
February 14, 2025
Study Record Updates
Last Update Posted (Actual)
June 11, 2025
Last Update Submitted That Met QC Criteria
June 10, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 8527-013
- MK-8527-013 (Other Identifier: MSD)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.